Shave biopsies are often uncomfortable during the healing process. This is a preliminary study to determine if patients and clinicians prefer using PolyMem formulating dressings on shave biopsy sites compared to the current standard of practice, which is antibiotic ointment covered with a band-aid type dressing.

A Single Site, Three Arm, Open Label Comparative Preference Study to Evaluate the Preference of Consumers and Health Care Professionals for the Use of Shapes by PolyMem Wound Dressings and Shapes by PolyMem Silver Wound Dressings, Each Compared to Antibiotic Ointment Covered With a Band-aid Type Dressing (Current Standard of Practice) and to Each Other in the Post-biopsy Management of Shave Biopsies. Each Participant Serves as Own Control. A Blinded Third Party Physician Will Evaluate and Compare the Wounds Based on Photos Taken at the Various Follow-up Points..

Preference by both clinician and consumer of dressing choice in managing shave biopsy sites. [ Time Frame: At completion of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluations and comparisons by both treating physician and blinded physician of each site for differences in inflammation, signs of possible infection, reepithelialization and cosmetic appearance [ Time Frame: At completion of protocol ] [ Designated as safety issue: No ]

After the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem dressing.

Device: Shapes by PolyMem dressing

Shapes by PolyMem dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site

2

Arm 2: after the two biopsies, one site will be covered with the antibiotic ointment and the band-aid type bandage (physician's current standard of care) and the other site will be covered the Shapes by PolyMem Silver dressing.

Device: Shapes by PolyMem Silver Dressing

Shapes by PolyMem Silver dressing on one site compared to antibiotic ointment covered with band-aid type dressing on second site

3

Arm 3: after the two biopsies, one site will be covered with Shapes by PolyMem dressing and the other site will be covered the Shapes by PolyMem Silver dressing.

Device: Shapes by PolyMem on one site and Shapes by PolyMem Silver dressing on second site

Shapes by PolyMem dressing on one site. Shapes by PolyMem Silver dressing on other site.

Detailed Description:

Only individuals who require 2 shave biopsies on the same treatment day will be entered in the study. Each participant serves as their own control.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Individuals that are going to have two shave biopsies performed on the same day will be evaluated for inclusion in the study.

Exclusion Criteria:

Those that have used systemic corticosteroids in the last three months.

Those with any medical condition leading to immunosuppression

Those with a history of keloid formation

Those with documented compromised wound healing potential

History of psoriasis or eczema in the last 2 years

Those with an active infection

Those that use aspirin or non-steroidal anti-inflammatory drugs more than 3 times per week for pain (daily low dose aspirin use for cardiovascular health is not an exclusion criteria)

Those that have inflammatory conditions such as rheumatoid arthritis or Crohn's disease

Those that have clinical signs of malnutrition that could interfere with wound healing

Those that have a history of allergies to any wound dressing or medical tape

Those that are not able to change the dressing themselves and do not have anyone in their household that can change the dressings if needed.

Those younger than 18 years old

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727870

Locations

United States, Illinois

Chicago Skin Clinic

Chicago, Illinois, United States, 60641

Sponsors and Collaborators

Ferris Mfg. Corp.

Chicago Skin Clinic

University of Minnesota - Clinical and Translational Science Institute